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NCT04824794 · OUTCOME

Expansion Part B: Time to Next Therapy (TTNT)

GEN3014 Trial in Relapsed or Refractory Hematologic Malignancies · Source last updated 2026-05-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 4 years 3 months

What was measured

TTNT for participants in the Expansion Part B was defined as the time from randomization to the start of subsequent anti-cancer therapy. Participants who withdrew consent or were lost to follow up or died due to causes other than disease progression were censored at their last disease assessment.

Analysis population: Full Analysis set included all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC).

Groups in this outcome

RRMM Expansion Part B: Daratumumab

Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by subcutaneous (SC) injection in 28-day treatment cycles.

RRMM Expansion Part B: GEN3014

Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
RRMM Expansion Part B: Daratumumab43
RRMM Expansion Part B: GEN301445

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RRMM Expansion Part B: Daratumumab9.3Not reported6.814.2Not reported
RRMM Expansion Part B: GEN30149.6Not reported7.9NACould not be estimated due to the low number of events.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.8
        upper Limit
        14.2
        value
        9.3
      2. comment
        Could not be estimated due to the low number of events.
        group Id
        OG001
        lower Limit
        7.9
        upper Limit
        NA
        value
        9.6
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    2. group Id
      OG001
      value
      45
    units
    Participants
description
TTNT for participants in the Expansion Part B was defined as the time from randomization to the start of subsequent anti-cancer therapy. Participants who withdrew consent or were lost to follow up or died due to causes other than disease progression were censored at their last disease assessment.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by subcutaneous (SC) injection in 28-day treatment cycles.
    id
    OG000
    title
    RRMM Expansion Part B: Daratumumab
  2. description
    Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.
    id
    OG001
    title
    RRMM Expansion Part B: GEN3014
param Type
MEDIAN
population Description
Full Analysis set included all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC).
reporting Status
POSTED
time Frame
Up to approximately 4 years 3 months
title
Expansion Part B: Time to Next Therapy (TTNT)
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice